Calamine Plus Pramoxine HCl

Product NDC: 81522-959
11-digit product format: 815220959
Labeler code: 81522
Product ID: 81522-959_3cd1933c-6340-50d6-e063-6294a90aca32
Type: HUMAN OTC DRUG
Nonproprietary name: Calamine Plus Spray
Dosage form: AEROSOL, SPRAY
Route: TOPICAL
Labeler: FSA Store Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-08-12
Substance: FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength: 5; 75; 10 mg/g; mg/g; mg/g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Calamine Plus Pramoxine HCl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	5 mg/g
ZINC OXIDE	75 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1544717	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3cd18f96-34f7-3f2c-e063-6294a90a3b7e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81522-959-01	Calamine Plus Pramoxine HCl	116 g in 1 CAN	AEROSOL, SPRAY	116		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 128 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AOSI HEALTHCARE BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	a28b920c-0bb8-4b5a-addd-26ea164e036e	2024-09-25	Warnings	Exact identifier application number: M017
anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger Company	067e718a-ec0b-4895-8f9f-82d64ab4c7b4	2024-09-24	Warnings	Exact identifier application number: M017
topcare anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Topco Associates LLC	e0fb332a-2903-41ef-b35b-7cd3a74cff99	2024-09-24	Warnings	Exact identifier application number: M017
equaline anti itch	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	83cd9f60-a4c4-4dea-97a7-cd96aade9e88	2024-09-24	Warnings	Exact identifier application number: M017
good sense itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	L. Perrigo Company	162fe0a3-3995-4e6f-94ed-f839b2b0c80e	2024-09-24	Warnings	Exact identifier application number: M017
Caring Mill Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Veridian Healthcare	22ca137a-576c-a13c-e063-6394a90ae7fc	2024-09-23	Warnings	Exact identifier application number: M017
Signature Care Anti Itch	HYDROCORTISONE	Safeway	ed0eb068-3ce6-423d-a7f8-c3456b7f6040	2024-09-23	Warnings	Exact identifier application number: M017
members mark hydrocortisone	HYDROCORTISONE	Sam's West Inc	218f0dcd-fa67-4935-8019-ecbbd53ed2f7	2024-09-23	Warnings	Exact identifier application number: M017
anti itch	HYDROCORTISONE	Meijer, Inc.	a07496e0-6fc2-4190-8a01-f513134ffb92	2024-09-23	Warnings	Exact identifier application number: M017
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Whitestone Products LLC	2301fed7-0fa9-450d-8b1b-006f53235be0	2024-09-21	Warnings	Exact identifier application number: M017
Tibetree Cheezheng Joint Analgesic Patch	CAMPHOR	Tibet Cheezheng Tibetan Medicine Co. Ltd	65a8a63f-1864-473e-be72-7840a6a5dee7	2024-09-20	Warnings	Exact identifier application number: M017
Cold Ice Analgesic Gel	MENTHOL	Dabur India Limited	22915b2f-5f76-3e38-e063-6394a90a07b4	2024-09-20	Warnings	Exact identifier application number: M017
Exchange Select Hydrocortisone	HYDROCORTISONE	Army & Air Force Exchange Service	1b709db3-7dc1-4756-a8a0-dddda875dc57	2024-09-19	Warnings	Exact identifier application number: M017
Theraworx PM Nighttime Maximum Strength Pain Relief	LIDOCAINE HYDROCHLORIDE	AVADIM HOLDINGS, INC.	bc8cb476-9a47-47b3-ad78-a6ecec9ee66f	2024-09-19	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Stratus Pharmaceuticals Inc	e1a8d4a7-01f7-4bab-8d09-875c461b3b61	2024-09-19	Warnings	Exact identifier application number: M017
Camphor Spirit	CAMPHOR 10%	Strategic Sourcing Services, LLC	2216d799-7f6f-cab7-e063-6294a90a8d6c	2024-09-14	Warnings	Exact identifier application number: M017
Meijer Analgesic Lidocaine Topical Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	f5d39be6-3b91-4ba1-9015-fd3ffbbdf4aa	2024-09-12	Warnings	Exact identifier application number: M017
leader anti itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Cardinal Health 110, LLC. dba Leader	e1aab35b-80d9-4515-afb7-8c662bc5d028	2024-09-11	Warnings	Exact identifier application number: M017
LactiGo	MENTHOL	LactiGo, Inc.	849c3601-2bc8-0991-e053-2a91aa0a5e7f	2024-09-03	Warnings	Exact identifier application number: M017
Hempvana Ultra Strength Pain Relief Gel Platinum - Arthritis	MENTHOL 8%	Telebrands Corp	c22cf1a5-0d5d-5ea5-e053-2995a90a333b	2024-09-02	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1544717	calamine 8 % / pramoxine HCl 1 % Topical Spray	PSN	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	1
1544717	calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray	SCD	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	1
1544717	calamine 8 % / pramoxine hydrochloride 1 % Topical Spray	SY	3cd18f96-34f7-3f2c-e063-6294a90a3b7e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81522-959-01	81522095901	116 g in 1 CAN (81522-959-01)	116 g	2025-08-12	No	No	Current